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The Efficacy and Safety of Caffeic Acid for Esophageal Cancer (CAEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03070262
Recruitment Status : Active, not recruiting
First Posted : March 3, 2017
Last Update Posted : April 30, 2020
Sponsor:
Collaborators:
Anyang Tumor Hospital
150th Hospital of PLA
Information provided by (Responsible Party):
The First Affiliated Hospital of Henan University of Science and Technology

Brief Summary:
Caffeic acid can target inhibit GASC1 (gene amplified in squamous cell carcinoma 1, also known as KDM4C and JMJD2C) expression and GASC1 is confirmed to be a new oncogene in several cancers including esophageal cancer. This study aims to investigate the efficiency and safety of coffeic acid in chinese advanced esophageal squamous cell cancer (ESCC).

Condition or disease Intervention/treatment Phase
Esophagus Cancer Drug: CA Drug: placebo group Phase 3

Detailed Description:

Background: More than half of global esophageal cancer cases came from China.80 percentage patients were diagnosed with advanced disease and suffered from the poor outcome.With the development of target therapy among cancers,the overall survival and life quality of patients has been continuous improved recently.However,there had little reports focusing on target therapy in esophageal cancer . Caffeic acid as an ordinary drug is used for thrombocytopenia when patient received chemotherapy. Newly studies shown caffeic acid can target inhibit GASC1 expression, and GASC1 is confirmed to be a new oncogene in esophageal cancer.

Aim: to investigate the efficiency and safety of caffeic acid in chinese advanced esophageal squamous cell cancer.

Methods: 240 advanced ESCC patients will be randomized to two arms: CA group (receiving coffeic acid treatment) or placebo group. In CA group, patients will receive coffeic acid treatment: 100-200mg, tid, po, 2 weeks treated then 1 week black interval(weight >50kg, 200mg per time, weight < or =50kg, 100mg per time); in placebo group, the same shape placebo tablets will be deliveried to patients. 1 years follow-up for both groups patients.Patients in both arms can receive any other ways of anti cancer therapy in the same time.

Primary endpoints: 3 months PFS; Second endpoints: 1 year OS

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Caffeic Acid for Advanced Esophageal Squamous Cell Cancer: A Randomized, Double-blind, and Multicenter Trial in Chinese Patients
Study Start Date : January 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CA group
caffeic acid (300mg, tid, po) continue given until progression of disease or death, or patients are unable to bear the side effects
Drug: CA
caffeic acid, 300mg, tid, po

Placebo Comparator: placebo group
the same shape placebo tablets continue given until progression of disease or death, or patients are unable to bear the side effects
Drug: placebo group
placebo tablet, 3 tablets, tid, po




Primary Outcome Measures :
  1. 3 months PFS % [ Time Frame: 3 months ]
    The percentage of 3 months progression-free survival (PFS) after random allocation. PFS was defined as the time from randomisation to disease progression or death as assessed by the treating physicians in the study through CT scan, gastroscopy and biopsy pathology, X-ray barium meal.


Secondary Outcome Measures :
  1. 1 year OS % [ Time Frame: 1 year ]
    The percentage of 1 year overall survival (OS) after random allocation. The follow-up will be done every 3 months through phone call, investigator visiting, and medical recording review.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chinese
  • esophageal squamous cell cancer
  • stage IV or disease recurrence
  • chemotherapy, or radiotherapy, or palliative care is going on

Exclusion Criteria:

  • PS (performance status): ≥ 3
  • severe hepatic and renal dysfunction
  • hypercoagulability
  • thrombocytosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070262


Locations
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China, Henan
The Clinical Medical College, The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471003
Sponsors and Collaborators
The First Affiliated Hospital of Henan University of Science and Technology
Anyang Tumor Hospital
150th Hospital of PLA
Investigators
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Study Chair: Shegan Gao, PhD The Clinical Medical College, The First Affiliated Hospital of Henan Science and Technology
Publications of Results:

Other Publications:
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Responsible Party: The First Affiliated Hospital of Henan University of Science and Technology
ClinicalTrials.gov Identifier: NCT03070262    
Other Study ID Numbers: CAEC
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by The First Affiliated Hospital of Henan University of Science and Technology:
esophageal cancer
caffeic acid
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases